NDC | 59779-768-12 |
Set ID | 91063edd-1e7e-41e9-8412-b14ef3749018 |
Category | HUMAN OTC DRUG LABEL |
Packager | CVS Pharmacy,Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each packet) – Multi Symptom Severe Cold
- Active ingredients (in each packet) - Nighttime Severe Cold and Cough
- Purpose - Multi Symptom Severe Cold
- Purpose - Nighttime Severe Cold and Cough
- Uses - Multi Symptom Severe Cold
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Uses - Nighttime Severe Cold and Cough
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- temporarily relieves these symptoms due to a cold:
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- minor aches and pains
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- minor sore throat pain
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- headache
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- nasal and sinus congestion
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- runny nose
- ▪
- sneezing
- ▪
- itchy nose or throat
- ▪
- itchy, watery eyes due to hay fever
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- cough due to minor throat and bronchial irritation
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- temporarily reduces fever
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Warnings – Multi Symptom Severe Cold /Nighttime Severe Cold and Cough
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
- ▪
- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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Do not use - Multi Symptom Severe Cold
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- in a child under 12 years of age
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- if you are allergic to acetaminophen
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
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- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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Do not use - Nighttime Severe Cold and Cough
- ▪
- in a child under 12 years of age
- ▪
- if you are allergic to acetaminophen
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
- ▪
- with any other product containing diphenhydramine, even one used on skin
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- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- Ask a doctor before use if you have - Multi Symptom Severe Cold
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Ask a doctor before use if you have - Nighttime Severe Cold and Cough
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- glaucoma
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- a sodium restricted diet
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- trouble urinating due to an enlarged prostate gland
- ▪
- a breathing problem such as emphysema or chronic bronchitis
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
- Ask a doctor or pharmacist before use if you are - Multi Symptom Severe Cold
- Ask a doctor or pharmacist before use if you are - Nighttime Severe Cold and Cough
- When using this product - Multi Symptom Severe Cold
- When using this product - Nighttime Severe Cold and Cough
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Stop use and ask a doctor if – Multi Symptom Severe Cold /Nighttime Severe Cold and Cough
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- nervousness, dizziness, or sleeplessness occurs
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- symptoms do not get better or worsen
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- pain, cough or nasal congestion gets worse or lasts more than 7 days
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- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions – Multi Symptom Severe Cold
- ▪
- do not use more than directed
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- take every 4 hours, while symptoms persist; Do not to take 6 packets in 24 hours or as directed by a doctor
- Age
- Dose
- Adults and children 12 years of age
- One packet
- Children under 12 years of age
- Do not use
Directions Nighttime Severe Cold and Cough
- ▪
- do not use more than directed
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- take every 4 hours while symptoms persist;; not to exceed 5 packets in 24 hours or as directed by a doctor
- Age
- Dose
- Adults and children 12 years of age
- One packet
- Children under 12 years of age
- Do not use
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- Dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes
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- If using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
- Other information - Multi Symptom Severe Cold
- Other information - Nighttime Severe Cold and Cough
- Inactive ingredients - Multi Symptom Severe Cold
- Inactive ingredients - Nighttime Severe Cold and Cough
- Questions or comments?
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Package/Label Principal Display Panel
Multi Symptom Severe Cold 6 PACKETS + NIGHTTIME 6 PACKETS = 12 PACKETS TOTAL
Compare to the active ingredients in Theraflu® Multi Symptom Severe Cold* & Theraflu® Nighttime Severe Cold & Cough*
Multi Symptom
Severe Cold
ACETAMINOPHEN - Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr – Cough suppressant
PHENYLEPHRINE HCl – Nasal decongestant
Relieves:
- •
- Nasal congestion
- •
- Sore throat pain
- •
- Cough
- •
- Headache
- •
- Body ache
- •
- Fever
Green Tea & Honey Lemon Flavors
6 PACKETS
NIGHTTIME
Severe Cold & Cough
ACETAMINOPHEN - Pain reliever; Fever reducer
DIPHENHYDRAMINE HCl – Antihistamine; Cough suppressant
PHENYLEPHRINE HCl – Nasal decongestant
Relieves:
- •
- Nasal congestion
- •
- Sore throat pain
- •
- Cough
- •
- Headache
- •
- Body ache
- •
- Fever
- •
- Runny nose
- •
- Sneezing
Honey Lemon Flavor Infused with Chamomile &White Tea Flavors
6 PACKETS
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2017 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
Money Back Guarantee
*These products are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Multi-Symptom Severe Cold and Theraflu® Nighttime Severe Cold & Cough.
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INGREDIENTS AND APPEARANCE
MULTI SYMPTOM SEVERE COLD AND NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-768 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-768-12 1 in 1 CARTON; Type 0: Not a Combination Product 09/21/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CARTON 6 Part 2 1 CARTON 6 Part 1 of 2 CVS HEALTH MULTI SYMPTOM SEVERE COLD MULTI SYMPTOM SEVERE COLD
acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARAMEL (UNII: T9D99G2B1R) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CITRATE (UNII: EE90ONI6FF) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/21/2015 Part 2 of 2 CVS HEALTH NIGHTTIME SEVERE COUGH AND COLD NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/17/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/21/2015 Labeler - CVS Pharmacy,Inc. (062312574)